BETA

80 Amendments of Michèle RIVASI related to 2011/0152(COD)

Michèle RIVASI

Proposal for a directive
Recital 10

(10) The undesired effects on the human body are dependent on the frequency of the electromagnetic field or radiation to which it is exposed, from 0 Hz until 100 kHz and above 100 kHz, therefore two different exposure limitation systems need to be considered to protect workers exposed to electromagnetic fields.deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Recital 13

(13) Since this Directive is an individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work, that Directive therefore applies to the exposure of workers to electromagnetic fields, including regarding the effects of long-term exposure, without prejudice to more stringent and/or specific provisions contained in this Directive.

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Recital 14

(14) The power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in order to empower it to make purely technical amendments of the Annexes to this Directive, in line with the adoption of directives in the field of technical harmonisation and standardisation and as a result of the technical progress, changes in the most relevant harmonised European standards or specifications and new scientific findings concerning electromagnetic fields, as well as to adjust the ~~orientation and action values and the~~ related lists of activities, workplaces and types of equipments. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Recital 16

(16) A system including exposure limit ~~values, orientation~~ values and action values, wherever applicable, should be seen as a means to facilitate the provision of a high level of protection against the established adverse health and safety effects that may result from exposure to electromagnetic fields. But such a system may conflict with specific conditions in certain activities, such as specific medical procedures using magnetic resonance techniques or military operations where interoperability is required and where internationally accepted standards providing an equivalent protection of workers subject to specific exposure situations are already in place. It is therefore necessary to take these particular conditions into account.

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Recital 17 a (new)

(17 a) The Commission shall, within 5 years, assess the scientific evidence for long-term effects caused by electromagnetic field exposure, and present a proposal for revising the directive in order to include the protection of workers to such long-term effects.

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 1 – paragraph 1

1. This Directive, which is the 20th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC, lays down minimum requirements for the protection of workers from risks to their health and safety arising or likely to arise from exposure to electromagnetic fields ~~(0 Hz to 300 GHz)~~ during their work.

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 1 – paragraph 2

2. This Directive relates to the direct risks to the health and safety of workers due to known short-term adverse effects in the human body caused by induced electric or magnetic fields, by energy absorption and by contact currents. It also covers indirect health and safety effects.deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 1 – paragraph 3

3. ~~This Directive does not address long- term effects~~Regarding long-term effects, the obligations specified by the Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work shall apply.

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 2 – paragraph 1 – point b

(b) ‘adverse health effects’: biological effects that have a detrimental effect on mental, physical and/or general well- being of exposed workers. In this Directive, only short-term effects are considered;deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 2 – paragraph 1 – point c2

(c) ‘direct effect’: effect on the human body directly provoked by the presence of a strong magnetic or electric field, for example the stimulation of muscles, nerves or sensitory organs, tissue heating, vertigo or headaches; (In the Commission's text there are two point c; (Article 2 - paragraph 1 -deleted Or. en amendment is referring to the second point c) ~~- this~~

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 2 – paragraph 1 – point d

(d) ‘indirect effect’: effect on an object, due to the presence of a strong electric or magnetic field, which may become the cause of a safety or health hazard, for example contact currents, ferromagnetic projectiles or interference with active implantable medical devices;deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 2 – paragraph 1 – point e

(e) ‘exposure limit values’: limits on exposure to electromagnetic fields which have been established on the basis of known health effects and biological considerations. Compliance with the exposure limits values for health effects will ensure that workers exposed to electromagnetic fields are protected against all known adverse health effects. Compliance with the exposure limits values for safety effects will ensure that workers exposed to electromagnetic fields are protected against all known adverse health and safety effect, in particular thermal effects and electrical stimulation of tissues;

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 2 – paragraph 1 – point f

(f) ~~‘orientation value’ and~~ ‘action value’: directly measurable frequency-dependent parameters of electromagnetic field exposure, the magnitude of which is established to ensure by simplified assessment the compliance with relevant exposure limit values or in terms of electric field strength (E), magnetic field strength (H), magnetic flux density (B) and power density (S), and at which one or more of the measures specified in this Directive must be taken,

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 2 – paragraph 2 – subparagraph 1

The ‘orientation value’ referred to in point (f) of paragraph 1 corresponds to a field level where no adverse health effect should be noticed under normal working conditions and for persons not being part of a group at particular risk. As a consequence, the depth of the risk assessment procedure can be reduced to a minimum. Compliance with the orientation value will ensure compliance with the relevant exposure limit values for safety and health effects.deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 2 – paragraph 2 – subparagraph 2

2. The ‘action value’ referred to in point (f) of paragraph 1 corresponds to the maximum directly measurable field for which automatic compliance with the exposure limit value is guaranteed. Any exposure level between the ‘orientation value’ and the ‘action value’ requires more extensive evaluations and preventive measures. Compliance with the action value will ensure compliance with the relevant exposure limit values for health effects.deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 3 – title

Exposure limit ~~values, orientation~~ values and action values

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 3 – paragraph 1 – subparagraph 1

1. Exposure limit values ~~as well as orientation and action values for both electric and magnetic fields in the frequency range from 0 to 100 kHz~~for electromagnetic fields shall be as set out in Annex II.

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 3 – paragraph 1 – subparagraph 2

For exposure levels above the action value, appropriate verifications shall demonstrate that the exposure level is not exceeding the relevant exposure limit value for health effects. For exposure levels above the orientation value, appropriate verifications shall demonstrate that the exposure is not exceeding the relevant exposure limit values for safety and health effects or by demonstrating that the exposure level is below the action value. In the latter case, preventive measures and information to workers shall be adapted.deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 3 – paragraph 2 – subparagraph 1

2. ~~Exposure limit values and a~~Action values for ~~both~~ electr~~ic and~~ omagnetic fields ~~in the frequency range from 100 kHz to 300 GHz~~ shall be as set out in Annex III.

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 3 – paragraph 2 – subparagraph 2

~~For exposure of levels above the action level, appropriate verifications shall demonstrate that the exposure is not exceeding the relevant exposure limit value for health effects.~~deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 3 – paragraph 3

3. For the assessment, measurement and/or calculation of workers' exposure levels to electromagnetic fields likely to be significantly below the action value, simple methods may be used. For the other cases where the exposure level is likely to be close or above the action value, Member States shall give guidance based on available harmonised European standards established by the European Committee for Electrotechnical Standardisation (CENELEC) or on other scientifically-based standards or guidelines.deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 3 – paragraph 4

4. ~~By way of derogation, paragraphs 1 and 2 shall not apply to medical applications using the magnetic resonance effect~~Without prejudice to paragraph 5, workers may not be exposed above the exposure limit values. For specific situations where the exposure of a worker may occasionally exceed the exposure limit values and where, in duly justified circumstances, given the state of the art and the specific characteristics of workplaces, it is not possible to comply with the exposure limit values despite the technical and/or organization measures taken, Member States may put in place a system authorizing work under controlled conditions and on the ~~following related activities: integral system testing before releas~~basis of a comprehensive risk assessment setting out the actual exposure levels and their likelihood and comparing them to the exposure limit values defined in Annex II. Such system must guarantee that the resulting risks are reduced to a minimum and that the fwor ~~shipment, installation, cleaning, maintenance, research and development activities~~kers concerned are subject to increased health surveillance. An authorization shall be withdrawn as soon as the justifying circumstances no longer obtain. Member States shall forward to the Commission a list of such authorizations in the report referred to in Article 17a of Directive 89/391/EEC indicating the exact reasons and circumstances which made them decide to grant them. In these particular case~~s, specific~~ of medical applications using the magnetic resonance effect where the exposure of a worker may occasionally exceed the exposure limit values, additional protection measures shall be put in place. For this purpose the Commission shall consult the existing working groups and proceed according to the measures set out in Annex IV.

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 3 – paragraph 6

6. Without prejudice to paragraphs 4 and 5, workers may not be exposed above the exposure limit values for health effects. For specific situations where these values may temporarily be exceeded, Member States may put in place a system authorising work under controlled conditions and on the basis of a comprehensive risk assessment setting out the actual exposure levels and their likelihood and comparing them to the exposure limit values defined in Annexes II and III. Such specific situations shall be reported to the Commission in the report referred to in Article 17a of Directive 89/391/EEC.deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 4 – title

~~Determination of exposure and assessment of risks~~Assessment of risks and determination of exposure

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 4 – paragraph 1

1. In carrying out the obligations laid down in Articles 6(3) and 9(1) of Directive 89/391/EEC, the employer shall assess and, if necessary, measure and/or calculate the levels of electromagnetic fields to which workers are exposed. Assessment, measurement and calculation may be carried out using the guidance provided in Annexes II and III. For specific cases not referred to in these Annexes, the employer may use harmonised European standards established by CENELEC for relevant assessment, measurement and calculation situations. The employer shall also be entitled to use other scientifically based standards or guidelines if required by the Member State concerned. When relevant, the employer shall also take into accThe employer shall be in possession of an assessment of the risks in accordance with the Directive 89/391/EEC and shall identify which measures must be taken in accordance with this Directive. The risk assessment shall be recorded on a suitable medium, according to national law and practice. It may include a justification by the employer that the nature and the extent of the risks related to electromagnetic fields make a further detailed risk assessment unnecessary. The risk assessment shall be updated on a regular basis, particularly if there have been significant changes which could render it ount ~~the emission levels and other safety- related data provided by the manufacturers of equipment in accordance with relevant Union legislation~~of date, or when the results of health surveillance show this to be necessary.

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 4 – paragraph 1 a (new)

1 a. Except in cases of justified reasons related to data protection, this assessment shall be made public on request.

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 4 – paragraph 2

2. On the basis of the assessment of the levels of electromagnetic fields undertaken in accordance with paragraph 1, if any of the action values referred to in Annexes II or III is exceeded, the employer shall further assess and, if necessary, calculate whether the exposure limit values for health effects are exceeded.deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 4 – paragraph 3

3. The assessment, measurement and/or calculations referred to in paragraphs 1 and 2 need not be carried out in workplaces open to the public provided that an evaluation has already been undertaken in accordance with the provisions of Council Recommendation 1999/519/EC of 12 July 1999 on the limitation of exposure of the general public to electromagnetic fields (0 Hz to 300 GHz)9 , and the restrictions as specified therein are respected for workers and safety risks are excluded. Where equipment, intended for the public and complying with EU product legislation and especially Directives 1999/5/EC and 2006/95/EC are being used as intended these conditions are met.deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 4 – paragraph 4

4. The assessment, measurement and/or calculations referred to in paragraphs 1 and 2 shall be planned and carried out by competent services or persons at suitable intervals, taking into account the guidance given in Annexes II and III and taking particular account of Articles 7 and 11 of Directive 89/391/EEC concerning the necessary competent services or persons and the consultation and participation of workers. The data obtained from the assessment, measurement and/or calculation of the level of exposure shall be preserved in a suitable form so as to permit consultation at a later stage.deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 4 – paragraph 5 – point a

(a) the frequency ~~spectrum~~composition and the level, duration and type of exposure;

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 4 – paragraph 5 – point b

~~(b) the exposure limit values and action values referred to in Article 3 and Annexes II and III to this Directive;~~deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 4 – paragraph 5 – point b a (new)

(b a) any direct physical effects, in particular: effect on the human body directly provoked by the presence in electromagnetic field, for example tissue heating, the stimulation of muscles, nerves or sensory organs, vertigo or phosfenes.

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 4 – paragraph 5 – point b b (new)

(b b) any adverse health effects, in particular: biological effects that have a detrimental effect on mental, physical and/or general well-being of exposed workers;

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 4 – paragraph 5 – point b c (new)

(b c) any adverse safety effects, in particular: effects creating temporary annoyance or affecting cognition or other brain or muscle functions and may thereby affect the ability of a worker to work safely;

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 4 – paragraph 5 – point b d (new)

(b d) the exposure limit values and action values referred to in Article 3 and Annex II of this Directive;

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 4 – paragraph 5 – point c

(c) any effects concerning the health and safety of workers at particular risk ~~such as workers who have declared to the employer that they wear an Act~~, in particular workers who wear an active or passive Iimplanted Mmedical Ddevice ~~and women who have declared that they~~(such as cardiac peacemakers), workers who wear body worn medical devices (such as insulin pumps), workers with poor immune systems (such as persons with cancer) and women who are pregnant;

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 4 – paragraph 5 – point d – introductory part

(d) any indirect effects on an object, due to the presence in electromagnetic field, which may become the cause of a safety or health hazard, such as:

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 4 – paragraph 5 – point d – point i

(i) interference with medical electronic equipment and devices (including cardiac pacemakers and other implanted or body worn devices as referred to in point (c));

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 4 – paragraph 5 – point d – point ii

(ii) the projectile risk from ferromagnetic objects in static magnetic fields with a magnetic flux density greater than 30 mT;

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 4 – paragraph 5 – point d – point iv a (new)

(iv a) contact or limb currents;

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 5 – paragraph 1 – subparagraph 2 a (new)

Workers shall not be exposed above the exposure limit values unless the conditions under Article 4(3) are fulfilled. If, despite the measures taken by the employer to comply with this Directive, the exposure limit values are exceeded, the employer shall take immediate action to reduce exposure below these exposure limit values. The employer shall identify the reasons why the exposure limit values have been exceeded, and shall amend the protection and prevention measures accordingly in order to prevent them being exceeded again.

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 5 – paragraph 2 – introductory part

2. On the basis of the risk assessment referred to in Article 4, once ~~the~~any action values referred to in Article 3 and Annex~~es II and I~~ II are exceeded, the employer~~, unless the assessment carried out in accordance with Article 4(2) demonstrates that the exposure limit values are not exceeded and that safety risks can be excluded,~~ shall devise and implement an action plan comprising technical and/or organisational measures to prevent exposure exceeding the exposure limit values, taking into account in particular:

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 5 – paragraph 2 – point c a (new)

(c a) measures and procedures to manage spark discharges through technical means and the training of workers. (applies in electric field exposures);

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 5 – paragraph 3

3. On the basis of the risk assessment referred to in Article 45, workplaces where workers ~~could~~are likely to be exposed to electromagnetic fields exceeding the ~~orientation or~~ action values shall be indicated by appropriate signs in accordance with Annexes II and ~~III and~~ with Council Directive 92/58/EEC of 24 June 1992 on the minimum requirements for the provision of safety and/or health signs at work (ninth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) 10 . The areas in question shall be identified and access to them limited as appropriate. Where access to these areas is suitably restricted for other reasons and workers informed on the electromagnetic risks then signs and access restrictions specific to electromagnetic fields are not required.

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 5 – paragraph 4

4. In any event, workers shall not be exposed above the exposure limit values for health effects unless the conditions under Article 3(6) are fulfilled. If, despite the measures taken by the employer to comply with this Directive, the exposure limit values for health effects are exceeded, the employer shall take immediate action to reduce exposure below these exposure limit values. The employer shall identify the reasons why the exposure limit values for health effects have been exceeded, and shall amend the protection and prevention measures accordingly in order to prevent them being exceeded again.deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 8 – paragraph 1 – subparagraph 1

With the objective of prevention and early diagnosis of any adverse health effects due to exposure to electromagnetic fields, appropriate health surveillance shall be carried out in accordance with Article 14 of Directive 89/391/EEC. Those provisions, including the requirements specified for health records and their availability, shall be introduced with national law and/or practice.

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 8 – paragraph 1 – subparagraph 1 – point a (new)

(a) Monitoring of long-term effects A committee of independent experts is settled in order to review the scientific knowledge on the long-term effects of electromagnetic exposure, and in accordance with Article 17 of Directive 89/391, the Commission shall propose a revision of the present Directive to take into account these probable effects.

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 8 – paragraph 1 – subparagraph 2

For exposures in the frequency range up to 100 kHz, any undesired or unexpected health effect reported by a worker shall be transmitted to the person in charge of the medical surveillance who will take appropriate action in accordance with national law and practice.deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 8 – paragraph 1 – subparagraph 3

For exposure in the range from 100 kHz up to 300 GHz, and in any event where exposure above the exposure limit values is detected, a medical examination shall be made available to the worker(s) concerned in accordance with national law and practice. If health damage resulting from such exposure is detected, a reassessment of the risks shall be carried out by the employer in accordance with Article 4.deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 10 – paragraph 1 – point b

(b) take into account the technical progress, changes in the most relevant ~~harmonised European~~ standards or specifications, and new scientific findings concerning electromagnetic fields;

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Article 10 – paragraph 1 – point c

(c) make adjustments to the ~~orientation and~~ action values provided that compliance with the existing exposure limit values is maintained, ~~and of the related lists of activities, workplaces and types of equipments~~ mentioned in Annex~~es II and I~~ II.

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 1 – paragraph 1

Contact current (IC) between a person and an object is expressed in amperes (A). A steady state contact current occurs when a person is in contact with a conductive object in an electromagnetic field. In the process of making such a contact, a spark discharge may occur with associated transient currents.

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 1 – paragraph 8

Of these quantities, magnetic flux density (B), contact current (IL), electric and magnetic field strengths (E) and power density (S) can be measured directly.

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 2 – heading

Exposure ~~to electromagnetic fields in the frequency range from 0 Hz to 100 kHz~~limit values and action values

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 2 – part A – heading

A. EXPOSURE LIMIT~~ATION SYSTEM~~ VALUES

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 2 – part A – paragraph 1

The main principles underlying the protection system adopted for the range of frequencies up to 100 kHz (100 thousand cycles per second) are as follows: – taking due account of the latest international recommendations published by the specialised organisations recognised worldwide – introducing appropriate and ‘limited to purpose’ simplifications in order to facilitate the understanding and ‘in field’ implementation of the protection system – introducing in practice a ‘zoning system’ in which each activity can be classified, whereby the location of an activity in a determined zone has a direct impact on the extent of the risk assessment to be carried out by the employer and on the recommended preventive measures – limiting the number of cases where compliance with the actual exposure limits must be ensured because the measured exposure level is higher than the upper limit of the highest permitted zone (action level).deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 2 – part A – paragraph 1 – subparagraph 1 (new)

Depending on the frequency and distribution of the electromagnetic fields to which the worker is exposed, the following physical quantities and values are used to specify the exposure limit values:

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 2 – part A – paragraph 1 – subparagraph 2 (new)

1. Exposure limit values for health and safety effects due to electrical stimulation of tissues (expressed in RMS values) (a) the exposure limit value for whole body exposure is derived from the effect threshold for effects on the peripheral nervous system in the whole body and it also prevents stimulation of nerve fibres in the central nervous system and is expressed as electric fields generated in nervous tissue in the body (in V/m): f < 3 kHz - 0.8 V/m; from 3 kHz up to 10 MHz - 2.7x10-4f V/m; where f is the frequency expressed in Hertz (Hz); (b) the exposure limit value for head exposure is derived from the effect threshold for effects on the central nervous system in the head and is expressed as electric fields generated in nervous tissue in the body (in V/m): f < 10 Hz - 0.5/f V/m; from 10 Hz up to 25 Hz - 0.05 V/m; from 25 Hz up to 400 Hz - 0.002f V/m; from 400 Hz up to 3 kHz - 0.8 V/m; from 3 kHz up to 10 MHz - 2.7x10-4f V/m; where f is the frequency expressed in Hertz (Hz); 2. Exposure limit values for health and safety effects due to thermal effects in tissues to prevent whole body heat stress and excessive localised heating of tissues (a) the exposure limit value for whole body exposure is derived from the effects threshold for whole body heat stress and is expressed as averaged SAR in the body (in W/kg): from 9 kHz up to 10 GHz - 0.4 W/kg (b) the exposure limit value for head and trunk exposure is derived from the effects threshold for whole body localised heat stress and is expressed as localised SAR in the body (in W/kg): from 9 kHz up to 10 GHz - 10 W/kg (c) the exposure limit value for limbs exposure is derived from the effects threshold for limbs localised heat stress and is expressed as localised SAR in the limbs (in W/kg): from 9 kHz up to 10 GHz - 20 W/kg where: - all SAR values are to be averaged over any six-minute period; - localised SAR averaging mass is any 10 g of contiguous tissue; the maximum SAR so obtained should be the value used for estimating exposure. These 10 g of tissue are intended to be a mass of contiguous tissue with nearly homogeneous electrical properties. In specifying a contiguous mass of tissue, it is recognised that this concept can be used in computational dosimetry but may present difficulties for direct physical measurements. A simple geometry such as cubic tissue mass can be used provided that the calculated dosimetric quantities have conservative values relative to the exposure guidelines; - for pulsed exposures in the frequency range 0.3 to 10 GHz and for localised exposure of the head in order to limit and avoid auditory effects caused by thermo elastic expansion, an additional exposure limit value is recommended. This is that the SA should not exceed 10 mJ/kg averaged over 10 g of tissue. 3. Exposure limit values for health and safety effects due to thermal effects in tissue to prevent excessive tissue heating at or near the body surface - the exposure limit values for the surface heating is derived from the effects threshold for the surface heating and is expressed as power density (in W/m2): from 10 GHz up to 300 GHz - 50 W/m2 where power densities are to be averaged over any 20 cm2 of exposed area and any 68/f1,05-minute period (where f is in GHz) to compensate for progressively shorter penetration depth as the frequency increases. Spatial maximum power densities averaged over 1 cm2 should not exceed 20 times the value of 50 W/m2; 4. Exposure limit values for health and safety effects due to exposure to static electric and magnetic field (a) the exposure limit value for whole body exposure to static magnetic field - 2 T (b) the exposure limit value for hands exposure to static magnetic field - 8 T Above 8 T Article 4(3) shall apply.

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 2 – part B - Heading

B. ~~EXPOSURE LEVELS AND EXPOSURE LIMIT~~ACTION VALUES

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 2 – part B – paragraph 1 – introductory part

~~In line with the most recent recommendations the following options have been taken:~~Depending on the frequency and distribution of the electromagnetic fields to which the worker is exposed, the following physical quantities and values are used to specify the action values, the magnitude of which is established to ensure by simplified assessment the compliance with relevant exposure limit values or at which one or more of the measures specified in this Directive must be taken. Action values correspond to estimated or measured field values at the workplace in absence of the worker, as maximum value at the worker position. When applying, the assessment of the measurement results shall take into account the measurement uncertainties determined in accordance with metrological practice. The main frequency (ies) to which the worker may be exposed must be determined. Manufacturers’ or installer’s data must be used whenever available. It is also necessary to assess whether the fields are sinusoidal or pulsed.

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 2 – part B – paragraph 1 – indent 1

~~- Actions values and Orientation values correspond to estimated or measured field values at the workplace in absence of the worker.~~deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 2 – part B – paragraph 1 – indent 2

~~- Exposure limit values for health effects and exposure limit values for safety effects are expressed as electric fields generated in nervous tissue in the body (in V/m)~~deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 2 – part B – paragraph 1 – indent 3

~~- For a worker at particular risk, as defined in Article 4 (5c), an individual assessment must be made in accordance with Annex II point E.~~deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 2 – part B – paragraph 2

~~Note 1: any situation where the measured value is higher than the action value, a thorough verification must be made according to Article 4(2).~~deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 2 – part B – paragraph 3

~~Note 2: f~~For any situation where the shape of the signal differs sufficiently from a sinusoid to affect the outcome, then peak values should be used as follows. For exposure limit values the peak value should be compared with the peak value of the induced electric field obtained by multiplying the values ~~of table 2.1~~in expressed in RMS values by 1.41. For magnetic and electric field levels outside the body, peak values of their rate of change with time should be compared with the ~~values of table 2.2 or 2.3~~exposure limit values or action values derived to prevent electrical stimulation of tissues multiplied by 8.9f (which is √2 2πf).

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 2 – part B – paragraph 4

~~For complex pulsed signals a thorough verification must be made according to Article 3(3).~~deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 2 – part B – Table 2.1

~~Table 2.1 Exposure Limit Values (expressed in RMS values)~~deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 2 – part B – paragraph 5

~~f is the frequency expressed in Hertz (Hz)~~deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 2 – part B – paragraph 6

~~The exposure limit value for safety effects is derived from the effect threshold for effects on the central nervous system in the head (CNS).~~deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 2 – part B – paragraph 7

The exposure limit value for health effects is derived from the effect threshold for effects on the peripheral nervous system (PNS) and it also prevents stimulation of nerve fibres in the central nervous system.deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 2 – part B – paragraph 8

~~Exposure limit values for static magnetic fields are given in table 2.3~~deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 2 – part B – Table 2.2

Frequency ~~Orientation Action value~~Head exposure Whole body ~~valu~~ exposure (Hz) (V/m) (V/m) 25 – 90 500 x 103/f 3 20 x 103 ~~1 – 25~~ 90 – 3000 2500 x 103/f 21800 x 103/f ~~25 – 90 500 x 103/f~~3000 - 105 170 600 ~~20 x~~ 105 – 1036 3600 ~~90 – 3000 500 x 10 /f 1800 x 103/f 3000 - 100000~~106 – 107 600 106/f 107 - 4 108 60 4 108 - 2 109 3 x 10-3 x f0.5 2 109 - 1010 137 1010 - 3 1011 ~~170~~ ~~600~~ 137

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 2 – part B – subheading 3

~~(RMS values)~~deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 2 – part B – Table 2.3

Frequency ~~Orientation Action value~~Head exposure Whole body ~~valu~~ exposure (Hz) (µT) (µT) 0 2 x 106 8 x 106 >0 – 1 (2-1.8 f) x 106 (5.67 – 5f) x 106 1–8 2 105/f2 0.666 x 106/f 8 – 25 25000/f 0.666 x 106/f 25 – 300 1000 0.666 x 106/f 300 - 3000 3 x 105/f 0.666 x 106/f 3000 - 9000 100 222 9000 - 20000 100 2 x 106 / f 20000 – 100000 2 x 106 / f 2 x 106 / f 105 - 107 --- 2 106 / f 107 - 4 108 --- 0.2 4 108 - 2 x 2 109 --- 10-5x f0.5 2 109 - 1010 --- 0.45 1010 - 3 1010 --- 0.45

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 2 – part B – paragraph 10

Note 1: ~~Values for 0 Hz in this tabl~~f is the afre ~~exposure limit values.~~quency expressed in Hertz (Hz) Note 2: Above 8 T Article 3(6) shall apply.

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 2 – part B – paragraph 11

Note 23: The action value for whole body exposure above 9 kHz and the ~~orient~~action value for head exposure above 20 kHz result from the exposure limit values for whole- body average SAR as defined in Annex III.

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 2 – part C

~~C. [...]~~ deleted Or. en(deleting the entire part C of Annex 2)

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 2 – part D

D. PREVENTION MEASURES and other conditions 1) For persons at particular risk referred to in Article 4(5)(c), individual assessments must be made in accordance to point E. 2) Zone of exposures under the orientation value: - Signage as appropriate 3) Zone of exposures above the orientation value but under the action value - Signage as appropriate - Delimitation measures (e.g. floor markings, fences) in order to limit or control access, as appropriate - Information and specific training of relevant workers - Verification of compliance with exposure limit values for safety effects or alternatively procedures to ensure adverse safety effects are managed. 4) Exposures above the action value: - Signage as appropriate - Delimitation measures (e.g. floor markings, fences) in order to limit or control access, as appropriate - Verification of compliance with exposure limit values for health effects. - Procedure to manage spark discharges through technical means and the training of workers. (Applies only where electric field exposures are in this zone.) - Appropriate delimitation and access measures - Information and specific training of relevant workers.deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 2 – part E

E. PERSONS AT PARTICULAR RISK Workers having declared themselves as wearing an Active Implantable Medical Device (AIMD) and women having declared themselves to be pregnant are considered to be persons at particular risk, as stated in Article 4(5)(c). Where a worker has declared to their employer that he or she wears an AIMD the employer shall carry out an assessment to determine what restriction on where they can work is needed to avoid interference to their implanted device. Advice on how to do this is provided by CENELEC (see EN 50527 and associate parts). It may be noted that principle underlying the CENELEC guidance is that interference will not occur when the fields is below the Reference Levels given in Council Recommendation 1999/519/EC on the limitation of exposure of the general public to electromagnetic fields (0 Hz to 300 GHz)11. Where a worker has declared to her employer that she is pregnant then the requirements of Council Directive 92/85/EEC on the introduction of measures to encourage improvements in the safety and health at work of pregnant workers and workers who have recently given birth or are breastfeeding12 apply. The employer shall enable the worker to avoid having to enter areas where exposures exceeding the exposure limits for the general public given in Council Recommendation 1999/519/EC, or its subsequent revisions.deleted

2011/12/05
Committee: ENVI

Michèle RIVASI

Proposal for a directive
Annex 3

deleted Or. en(deleting the entire Annex 3)

2011/12/05
Committee: ENVI